BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSOSTAR, 10P, DIA 15MM LOOP SIZE

    MDR report key: 14952840 · Received July 8, 2022

    Report

    Report Number
    2029046-2022-01551
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K193632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS UNKNOWN. THEREFORE, THE (B)(6) HAS BEEN ENTERED AS THE EVENT DATE UNDER DATE OF EVENT. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION 12-APR-2022. THE DEVICE EVALUATION WAS COMPLETED ON 15-JUN-2022. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION TEST OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SHAFT AREA NEAR THE CONNECTOR WAS DAMAGED LEAVING SOME INTERNAL PARTS EXPOSED. AS PART OF BWI¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: IF A LASSOSTAR¿ CATHETER IS USED WITH THE HELIOSTAR¿ CATHETER, DO NOT EXTEND THE HELIOSTAR¿ CATHETER BEYOND THE SHEATH TIP UNTIL THE LASSOSTAR¿ CATHETER HAS BEEN FULLY ADVANCED OUT OF THE GUIDEWIRE LUMEN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR, 10P, DIA 15MM LOOP SIZE AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED DAMAGE ON THE SHAFT LEAVING INTERNAL PARTS EXPOSED. INITIALLY IT WAS REPORTED THAT THE SHAFT WAS KINKED DURING INSERTION INTO THE HELIOSTAR. A NEW LASSOSTAR WAS NECESSARY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE DAMAGE DID NOT RESULT IN WIRES/INTERNAL COMPONENTS BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE OSCOR,GUIDESTAR 13.5F SHEATH WAS USED. THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE FOR A SHAFT BENT ISSUE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 15-JUN-2022, THE SHAFT AREA NEAR THE CONNECTOR WAS DAMAGED LEAVING SOME INTERNAL PARTS EXPOSED. THE DAMAGE ON THE SHAFT LEAVING INTERNAL PARTS EXPOSED WAS ASSESSED AS MDR REPORTABLE FOR A ¿BROKEN SHAFT (MID SHAFT)¿ ISSUE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 15-JUN-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844377 LASSOSTAR, 10P, DIA 15MM LOOP SIZE LASSOSTAR¿ CIRCULAR MAPPING CATHETER DRF BIOSENSE WEBSTER INC 30633520L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NON BWI- OSCOR,GUIDESTAR 13.5F SHEATH| UNK_HELIOSTAR CATHETER| UNK_LASSOSTAR CATHETER